Hatch-Waxman Patent Litigation
With 35 years’ experience in intellectual property litigation, Jeff is a practiced, strategic advisor to pharmaceutical companies, API manufacturers, biotechnology firms, and chemical and manufacturing companies.
As a partner at Green, Griffith & Borg-Breen, he serves clients in counseling, litigation, and opinion matters primarily relating to pharmaceutical, chemical and biochemical products and processes.
Jeff has been trying pharmaceutical patent infringement cases brought pursuant to the Hatch-Waxman Act since the late 1980’s; during that time he has represented pharmaceutical companies and API manufacturers regarding 505(b)(2) and ANDA submissions on a wide variety of products. Jeff has acted as lead counsel and tried numerous Hatch-Waxman litigation matters to verdict. In addition, he has counseled clients regarding filing and regulatory strategies.
“We take a holistic approach to this work,” Jeff says, “It’s about more than just a single matter. We work with each client to develop creative strategies in line with its business objectives, and then execute those strategies. Over the years, I’ve been able to work with some of the same clients multiple times as they’ve moved from one business to another or their business has expanded. It’s gratifying to earn their trust and help them resolve issues that are important to them.”
Jeff has litigated patent and trade secret disputes relating to the pharmaceutical, chemical and mechanical arts in various federal courts throughout the U.S. and the International Trade Commission, including as lead counsel in a number of jury trials. He also has led many patent appeals, including arguing to the U.S. Court of Appeals for the Federal Circuit.
In addition, Jeff has significant experience advising clients with respect to opinion matters, due-diligence issues, patent prosecution strategy, freedom-to-operate opinions and FDA issues relating to product exclusivities and labeling.
Jeff has been named an “IP Star” by Managing IP (2013-2015, 2018-2020), was recognized in Intellectual Asset Management’s (IAM) Patent 1000 in Litigation (2013-2017, 2019-2020), and was recognized as a “Life Sciences Star” by LMG Life Sciences (2020). He has been selected by his peers as a Leading Lawyer in Intellectual Property Law, Patent Law, and Trade Secrets/Unfair Competition Law, Leading Lawyers Network (2018-2021).
Before joining Green Griffith, Jeff was a partner with Merchant & Gould.